FILE | B | Study on the Development of Quality by Design (QbD) and how this can be Applied to the Most Common Parenteral Manufacturing Processes - QbD attachment model

FBO DAILY ISSUE OF JULY 02, 2008 FBO #2410
DOCUMENT

B -- Study on the Development of Quality by Design (QbD) and how this can be Applied to the Most Common Parenteral Manufacturing Processes - QbD attachment model

Notice Date: 6/30/2008
Notice Type: QbD attachment model
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: FDA-SOL-08-00747a
Archive Date: 7/31/2008
Point of Contact: David - Kordel,
E-Mail Address: david.kordel@fda.hhs.gov
Small Business Set-Aside: N/A
Description: FDA-SOL-08-00747a The Food and Drug Administration (FDA) is seeking full and open competition for vendors to conduct an analytical study on the development of Quality by Design (QbD) Case Studies and Guidance Elements on Parenteral Dosage Forms. Purpose : To reach a better understanding of the concept of Quality by Design (QbD) and how this can be applied to the most common parenteral manufacturing processes. Background : Pharmaceutical manufacturing is going through a major transition from quality assessment by testing the product at the end of manufacture to the more holistic control strategy of Quality by Design (QbD) and Process Analytical Technology (PAT). There is greater realization that an enhanced understanding of the pharmaceutical processes involved in product manufacture and in particular, appreciation of criticality of the process steps and the critical process parameters that control each of these steps are of vital importance to ensuring quality of manufactured products. With the advent of QbD, each pharmaceutical company is likely to implement science and risk based approaches to evaluate its own processes, determine their critical steps and necessary controls and establish a design space for each process. It is essential therefore, that companies have a common understanding to make the review process more consistent. Description of Work : The design for the study is shown in Figure 1 below. A typical Active Pharmaceutical Ingredient (API) that is widely available and is representative will be picked for this study. (See attachment) Figure 1: QbD for Parenterals – The Approach The study will involve the following steps: 1. Define the Critical Product Attributes of the Target Product Profile. The target product profile would include: a.Assay i.API source and control strategy b.Complete recovery of API activity upon reconstitution For small molecules, this is generally not a problem. For large molecules, and particularly for vaccines, it can be an unrealistic goal, and we can only strive for consistent recovery of activity. In cases where the concentration of formulation excipients is very low, or where organic co-solvent systems are used, powder ejection from the vial during freeze drying can be a significant issue c.Reconstitution i.Influence of formulation components ii.Thermal history of freezing iii.Potential effect of collapse, or micro-collapse, on reconstitution time d.Freedom from extraneous particulate matter i.May be related to slow, or incomplete, reconstitution Instability of freeze-dried solid can lead to particulate matter in reconstituted solid e.Stability i.Effect of residual moisture in freeze-dried solid Potential for transfer of moisture from stopper to freeze fried solid ii.Effect of vial headspace composition 2. Propose a formulation using key formulation design decisions. 3. Propose the manufacturing process. 4. Conduct a risk analysis using cause and effect process (Ishikawa diagram) to identify the variables that are like to impact the manufacturing process. 5. Risk Evaluation – classify the unit operations that are likely to have an impact on quality. 6. Identify the critical operating variables and material property variables that are like to have the maximum impact on the Critical Product Attributes. (Risk evaluation study using Risk = probability X impact and FMEA) 7. Design of Experiments. 8. Conduct the experiments in laboratory/pilot plant equipment. 9. Develop Formulation Design Space and Lyophilizer Design Space. 10. Propose control strategy to reduce risk. Deliverables: 1. Monthly teleconferences shall be on the 1st day of the month in the mornings (TBD). a. Shall maintain an on-going dialogue by communicating with the project officer & key study personnel via e-mail or telephone as necessary in order to provide periodic updates of study progress, status, and interim results related to various phases of the study. 2. Quarterly project reports in Word document shall be submitted to the project officer & key study personnel by the first day of the month (Q1 for method development, Q2 for formulation optimization, Q3 for process optimization, Q4 for final report). a. Keep and maintain all raw data collected during the performance of the study in laboratory notebooks and/or CDROM. 3. A final report in Word document shall be submitted to the project officer & key study personnel two weeks prior to the end of the 12-month time period of the study. 4. Presentation at the FDA of the final results shall be two weeks after the 12-month time period of the study. 5. Expect 1-day site visit from the project officer and/or key study personnel at vendor site at the 3-month and 9-month time periods of the study. 6. Vendor shall visit FDA facility in Silver Spring, Maryland for seminar presentation in PowerPoint format and/or for face-to-face discussion of the project at the 11-month time period of the study. 7. FDA retains full data rights to all information related to this study, including any subcontract works. EVALUATION OF VENDORS Evaluation Criteria Technical Approach (a) The offeror shall demonstrate the ability to design, collect and report data for the completion of all tasks listed in the SOW. The offeror shall have extensive publications and invited presentations record in the areas of manufacturing sciences, lyophilization, and Quality by Design. (15 points) (b) The offeror shall demonstrate the ability to assess and report risks from formulation and lyophilization failures due to variations in the facility, manufacturing process, design space and/or process control strategies (e.g. validation, sampling, monitoring, and acceptance criteria) as per the ICH Q9 guidance. (15 points) Data Access and Resources The offeror shall demonstrate primary data collection capability and the ability to work with databases and modeling programs. They shall demonstrate ability to work with quantitative data. (5 points) Project Management The offeror shall provide the information on the administration of the project. This includes management plans, methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures. (5 points) Evaluation Criteria Proposed Type of Personnel The offeror shall demonstrate that it employs doctoral level personnel requisite to perform: 1) high caliber qualitative and quantitative risk assessments; 2) high caliber formulation and manufacturing skills; and 3) scale-up and production design. (20 points) Organizational Experience (a) The offeror shall demonstrate experience in pharmaceutical engineering and manufacturing science. They shall demonstrate the ability to conduct and moderate workshops; establish liaison with academic, industrial and regulatory scientists; and have the ability to communicate science through presentations and peer-reviewed publications. (15 points) (b) The offeror shall demonstrate a thorough understanding of manufacturing processes for parenteral drug products from laboratory to pilot to commercial scale. They shall demonstrate the ability to identify and assess risks, specifically those associated with the production of lyophilized parenteral dosage forms. (15 points) Overall Price The offeror will provide the best overall value for the FDA in terms of cost, relevant experience and approach. (10 points) Total Points Scored Responses to this solicitation must not exceed 20 pages and follow the format of the evaluation criteria. The performance period will be one year from the time of award. This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 10:00 AM (1000) EST on July 8, 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 16 July 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
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Document(s): QbD attachment model; File Name: QbD Model (SS_QbDStudy_Fig1.doc); Link: https://www.fbo.gov//utils/view?id=1b5112ceb5b29dd372baedfd88de3bbf; Bytes: 47.50 Kb; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
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B -- Study on the Development of Quality by Design (QbD) and how this can be Applied to the Most Common Parenteral Manufacturing Processes - QbD attachment model